Pharmacovigilance QC Reviewer Team Lead IV
LOCATION: Plainsboro - hybrid (at least 3 days/week onsite is expected)
DURATION: 1 year
MUST HAVES:
1. Health care provider degree
2. In-depth PV case handling from case intake to submission of Individual Case Safety Reports (ICSRs)
3. Management experience
Job Requirements:
• In-depth pharmacovigilance case handling from case intake to submission of Individual Case Safety Reports (ICSRs)
• Extensive quality control of ICSRs to ensure compliance to internal and external health authority regulations (21 CFR FDA PostMarketing).
• Management/Team Lead over safety case management processes/operations
• Familiarity and experience working in safety databases (e.g. Argus)
• Identifies nonconformance and communicates via feedback or escalation as needed
Qualifications:
• Education Level: Minimum Bachelor’s degree, HCP degree is required e.g., pharmacist or nurse; advanced degree preferred
• Experience Level: Total of 8+ years –– 5+ Years pharmacovigilance Team Lead/Management and 3+ pharmaceutical experience, pharmacovigilance required.
• Analytical thinker with proficiency working with safety databases
• Proficiency in MS Outlook, Excel, Word
• Excellent written and verbal communication skills
...or be able to obtain a security clearance. Education and Experience: Ten (10) or more years experience. Bachelors degree in geology (preferred), environmental, or geotechnical engineering, or related field, from an accredited college or university required. Master...
Principal Associate, Audiovisual Producer (Executive Events)Capital One is seeking an Audiovisual Producer to join our Executive Event Production team in Richmond! The team consists of highly skilled audiovisual (AV) professionals, producing and technically operating a...
...Palo Alto Foundation Medical Group is seeking a full-time, BC/BE Cardiologist Location : Los Gatos/San Jose, CA Highlights: Physician-led and collegial environment On-site laboratory and imaging services Schedule flexibility and sabbaticals for work-life...
...Adjunct Geology Position Title: Adjunct Geology Department: Academics Campus: College Wide Additional Information: Please note: If you are a PSERS retiree, per PSERS guidelines, employment by the College as an adjunct faculty member will result in the...
...currently seeking a qualified Senior C++ Embedded Software Integration Engineer to join our clients organization and contribute to their ongoing... ...specialization in integration and field testing of robotic systems Experience with sensor configuration and data processing...